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2023 Combo Products Summit Agenda


Global Harmonization Opportunities In Combination Products

November 29, 2023 @ 10:25 am


11:25 am


Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC

Khaudeja Bano, VP Combination Product Quality, Amgen


Stiina Aarum, Scientific Officer, Scientific Advice and Protocol Assistance, European Medicines Academy(EMA)

Theresa Jeary, Principal Technical Specialist, Medicinal & Biologics, BSI

Joo Hee Kim, Professor, Regulatory Strategy center for Combination Products (RSCP), Ajou University

Mike Wallenstein, Global Head Regulatory Medical Devices, Combination Products & Precision Medicine, Novartis

John “Barr” Weiner, Associate Director for Policy in FDA’s Office of Combination Products (OCP), FDA

As regulatory bodies around the globe increasingly recognize the need to establish regulatory frameworks for combination products and other combined use systems, the implemented regulations and practices can diverge. What is the path forward to harmonize combination products and combined use experience? This panel discussion will bring in the perspectives from convergence under IMDRF and pharmaceutical expectations under ICH.

This conference IS co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services. The contents are those of the presenters and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. government.

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.


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